MAUDE Adverse Event Report: NINGBO UNICO PRODUCTS CO., LTD FLOOR.3TH, BUILDING HANDY SOLUTIONS; PAD, HEATING, POWERED

Model Number	25607
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer was using handy solutions neck and shoulder heating pad while laying in bed.She noticed a burning smell and found that the heating pad had burnt through and burned the back of her neck.She did not seek medical attention for the burn as it was minor.Testing was done on other units and determined that when the pad is laid on or bent in ways that are recommended against in the instructions for the device that overheating can occur and cause damage/burning of the device.

• Brand Name: HANDY SOLUTIONS
• Common Device Name: PAD, HEATING, POWERED
• Manufacturer (Section D): NINGBO UNICO PRODUCTS CO., LTD FLOOR.3TH, BUILDING; floor.3th, building 5, no.5; hongda rd; jiangbei, ningbo zhejiang 31503 3; CH 315033
• MDR Report Key: 24261000
• Report Number: 1000065475-2026-00001
• Device Sequence Number: 15853139
• Product Code: IRT
• UDI-Device Identifier: 00024291256076
• UDI-Public: 024291256076
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026
• Report Date (Section F): 02/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 25607
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/07/2026
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 02/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Female